Clinical Investigation

The medical profession must assume responsibility for assuring that research is potentially of significant value and ethically conducted. Benefits and risks of research must be distributed fairly, and particular care must be taken to avoid exploitation of vulnerable populations.

Research participants must be instructed about the nature of the research, consent from the research participant or an authorized representative must be truly informed and given freely, research must be planned thoughtfully, so that it has a high probability of yielding useful results, risks to patients must be minimized, and the benefit–to–risk ratio must be high enough to justify the research effort.

Each institution that receives federal support for research on humans is required to create an institutional review board. All proposed clinical research, regardless of the source of support, should be approved by the local institutional review board to assure that the research plans are reasonable and that research participants are adequately protected.

Although this formal system of review is designed to protect research participants, the premise on which all ethical research is based is mutual trust and respect between research participants and researchers. This premise requires that physician–investigators involved in designing or carrying out research have primary concern for the potential participants in these investigations.

Although the responsibility for assuring reasonable protection of human research participants resides with the investigators and the local institutional review board, the medical profession as a whole also has responsibilities. Clinical investigation is fraught with opportunities for conflicts to arise.

Physicians should avoid situations in which they are rewarded for particular outcomes. Physician–investigators may find themselves in dual roles with respect to patients who are also research participants. The health and welfare of the patient must always be the physician’s primary consideration. Physicians who refer patients for participation in research protocols must be satisfied that the program follows established ethical guidelines, provides for realistic informed consent, gives reasonable assurances of safety, and has an acceptable benefit–to–risk ratio. If the risks of the research become too great or if continued participation cannot be justified, the physician must be willing to advise the patient to withdraw. Physicians–of–record should not abdicate overall responsibility for patients whom they have referred to a research project. Giving finder’s fees to individual physicians for referring patients to a research project generates an unethical conflict of interest.

Research on delivery of health services raises issues about the protection of participants that have not yet been well examined. Researchers, physicians, and patients should thoughtfully balance the merits of innovation and the available means to monitor and protect research participants.

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